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Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00264459
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture

Condition or disease Intervention/treatment Phase
Grass Pollen Allergy Biological: Grass pollen formulation Other: Comparator Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.
Study Start Date : February 2003
Primary Completion Date : August 2008
Study Completion Date : September 2011
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo was given the same way as a sublingual preparation.
Other: Comparator
Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Other Name: Specific Immunotherapy
Experimental: Liquid formulation of an extract of a 6 grass pollen mixture

Sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.

The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose.

Biological: Grass pollen formulation

Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract.

The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.

Other Name: specific immunotherapy


Outcome Measures

Primary Outcome Measures :
  1. Symptom and Medication Score (SMS) [ Time Frame: 1.5 years of therapy ]
    The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.


Secondary Outcome Measures :
  1. Visual Rating Scale [ Time Frame: 1.5 years ]
    Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,

Exclusion Criteria:

Serious chronic diseases, Other perennial allergies

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264459


Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Ludger Klimek, M.D.
More Information

Additional Information:
Publications:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00264459     History of Changes
Other Study ID Numbers: Al0102st
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Allergopharma GmbH & Co. KG:
Sublingual immunotherapy
Rhinoconjunctivitis
Rhinitis
Asthma

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases